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You are here: Pharmya > All news > Updated version of European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-pre-authorisation-procedural-advice-users-centralised-procedure_en-0.pdf

Philippe Calandra 19 April 2021 All news
  • ← Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 April 2021
  • EU Individual Case Safety Report (ICSR) Implementation Guide →

Pharmya – Pharmacovigilance

PHARMYA is a French based company, dedicated to providing Pharmacovigilance services. Its mission is to support the pharmaceutical industry, biotechnology companies, research centers and their service providers in their efforts to comply with international Pharmacovigilance regulations.

In partnership with the region

Contact

  • PHARMYA
  • 315 Av. Saint Sauveur du Pin
  • 34980 Saint Clément de Rivière (Montpellier), France
  • Phone: +33 411 93 21 10
  • Email: info@pharmya.com
  • Website: www.pharmya.com

News

  • The ANSM publishes its haemovigilance report for 2023
  • User’s booklet – ANSM
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 October 2024
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